
Lupin is seeking a strategic and results-driven Quality Assurance Lead, Devices to lead quality systems and compliance activities for our growing portfolio of drug-device combination products. In this critical role, you will establish and maintain robust quality management systems, ensure adherence to FDA and global regulatory standards, and collaborate with cross-functional teams throughout the product lifecycle. The successful candidate will combine deep quality expertise with strong leadership, project management, and communication skills to drive a culture of quality, compliance, and continuous improvement while supporting the successful development and commercialization of innovative healthcare solutions. This role will be responsible for ensuring compliance with FDA, ISO 13485, ICH, and other applicable regulatory requirements.
This is an exciting opportunity for a quality-driven leader passionate about advancing patient-centric drug-device combination products and ensuring the highest standards of compliance and operational excellence.
The anticipated salary range for this position in New Jersey is $158,000.00 - $182,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
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Result Orientation
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Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.